BladeSafe, BladeSmart (Aust)

After extremely detailed measurements of sharp instruments & accessories that were once hand passed over the full range of procedures in all surgical specialties, I was able to calculate the critical overall design of the blade recess Important that the overall dimensions were no larger than the kidney dishes, device was intended to replace, as space on nurses instrument table is heavily allocated. 17 separate surgical sharps transfer safely in the device. Sales now in the millions. As contaminated waste, the plastic burns to water and carbon, & in use, is puncture proof. Has full FDA and TGA approval. It is immediately user friendly, prototype tested in actual surgery before the products design was finalised

Ability of users to shield their entire hand in the underside of the device, protects hands from size 5 through to size 9 from injury when transferring sharps such as scalpels and retractors such as skin hooks & cats paws. Users simply grip the underside of the main finger recess or the base of the long scalpel recess. Grips have also been provided along the top rim, maintaining a good grip when picking it up from above. Can also be grasped by sloping perimeter walls. Here only the thumb is on the outside sloping wall, other fingers fold around the bottom rim and are then safely shielded inside the underside cavity. This puts the thumb well below the top rim, well away from a blades entry path

Required the purchase of all available scalpel handles and blades from suppliers all around the world. The micro measurements involved in the main blade recess meant we were able to house all of these blades safely enough, to significantly reduce the chance of an injury from a loaded scalpel. Testing this recess saw the attempted insertion of the pincer grip of a small child, my 2 year old daughter, using a special blunt blade for this test. Main finger recess was designed to allow gloved hand from size 5 hand to size 9. All hand sizes could then insert their thumb and index finger to reach around the scalpel handle enough to get a complete pincer grip in order to remove it safely from the device

Stability was of crucial importance in the design brief, as the draped patient is often used as a resting place for the device. The1mm thickness of sloping side walls, with blade recess is uppermost, gives device the ability to grip the drape fabric well enough to be stable on draped surfaces it encounters, even steeply sloping drapes. When the device is used in the suture needle transfer mode, it is in the upside down position. Then the top rim of the device being 5mm in thickness, gives enough grab area on the drapes to resist movement. Bare weight of device of 81 grams, increases to 235grams when loaded with 2 needle holders & 2 tissue forceps. This extra weight also aids in grip & resisting any movement

From an advertising point of view, the device is unique. It is the 1st patented product in medical history usable in all surgeries. All other, common surgery items, are un-patent-able, such as blades, kidney dishes, sponges etc. We then provided a decal area on each side of device to pad print suppliers name or logo to advertise to staff in the OR. Pad printing is far cheaper and faster for a name change than changing steel stamped ingots into tool. To retain access to the tool we built it here in Sydney. at a cost of $75k for a 2 cavity unit. In Taiwan it was $25k, decision to use Swedish steel and a local toolmaker resulted in an exceptionally reliable service life of the tool and continuous production

Packaging was custom made for the device, to be extremely strong in shear strength while retaining flexibility. It had to maintain a vacuum inside the packaged device. Vacuum can be tested prior to opening by gripping it & pulling firmly, then releasing it. Springing back to its original position indicates vacuum is present & sterility is guaranteed. Still today, no other products used in theatre have this feature of sterility testing before opening. Reverse image carbon components from tools original construction, were used by our packaging contractor. Used to sandwich device between two halves of the packaging film as they were being adhered together and a vacuum was applied as the film was finally sealed

Angle of long side walls of device were designed to cause returning scalpel handle & blade to rotate as it fell. Landing in the main blade recess, kinetic energy of this rotating assembly causes it to roll over & lie flat every time. Wall angles enabled the device to be stackable, critical for storage in operating theatre storerooms where space is minimal. Stack ability let us to fit 96 sterile units per carton size of 45 x 45 x 56cm to economise gamma sterilisation costs. Maximising carton units gave the lowest possible freight costs selling directly to hospitals in the early days. It allowed us to fit the absolute max number of the device, into shipping containers we sent overseas to USA and NZ distributors